Open-Label Study of Lenalidomide in Combination With Oral Dexamethasone in the Treatment of Previously Untreated, Symptomatic Patients With Chronic Lymphocytic Leukemia
Phase 2
Completed
- Conditions
- Chronic Lymphocytic Leukemia
- Interventions
- Registration Number
- NCT01133743
- Lead Sponsor
- University Health Network, Toronto
- Brief Summary
This is a phase II, non-randomized, single institution study in symptomatic, previously untreated CLL patients. All patients will receive the study drug, lenalidomide, given PO daily continuously on a 28 day cycle at the starting dose level of either 2.5 mgs or 5 mgs with dose escalations to a target dose of 25mg daily. Oral dexamethasone at 12 mg PO daily will be administered on days 1-7, 14 and 21 of each cycle. Patients will be treated with lenalidomide and dexamethasone to 2 cycles past CR or to a maximum of 18 cycles, each cycle of 28 days duration. Primary endpoint is response.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
Inclusion Criteria
Not provided
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Lenalidomide and Dexamethasone Lenalidomide and Dexamethasone Lenalidomide target dose of 25 mg PO OD continuously (28-day cycle) using an initial dose escalation period. Oral dexamethasone 12 mg daily on days 1-7, 14 and 21 of each cycle.
- Primary Outcome Measures
Name Time Method Response rate 18 cycles (each cycle is of 28 days)
- Secondary Outcome Measures
Name Time Method Time to progression Participants will be followed until death
Trial Locations
- Locations (1)
University Health Network - Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada